Food and Drug Regulations

C.04.417 (1) In respect of the storage of source plasma, including storage during transportation, a fabricator shall ensure that the storage environment

• (a) is designed to maintain a temperature of -20°C or colder; and

• (b) remains consistently at a temperature of -20°C or colder.

(2) If the temperature of the environment rises above -20°C, the fabricator shall record the following information:

• (a) the reason for the elevated temperature;

• (b) the source plasma affected; and

• (c) the final disposition of the source plasma.

(3) If the temperature of the environment rises to between - 20°C and +10°C, the fabricator shall clearly and permanently label the container of the source plasma with the statement “Source Plasma — Salvaged” or “Plasma destiné au fractionnement — recyclé”.

(4) Subsection (3) does not apply if the temperature of the environment rises to between -20°C and -5°C for a single period lasting less than 72 hours.

(5) If the temperature of the environment rises above +10°C, the fabricator shall dispose of the source plasma.

(6) Paragraph (1)(b) and subsections (2) to (5) do not apply in respect of the storage of source plasma during transportation, if the transportation is not conducted by the fabricator.